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proton vision 7 0
Varian Medical Systems
Summary: Proton Vision 7 0 is a dialysis-access device by Varian Medical Systems, cleared by FDA via 510k. Key evidence includes improved oncologic and visual outcomes in proton therapy.
FDA Clearance Information
Pathway
510K
Number
K002312 ↗
Decision Date
August 30, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Proton Vision 7 0 was cleared by the FDA via the 510k pathway on August 30, 2000. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Proton Vision 7 0 is a medical device used in dialysis access. It is designed to facilitate efficient and safe vascular access for dialysis treatment, ensuring optimal blood flow and patient safety.
Clinical Applications
Commonly used in clinical scenarios requiring dialysis access, the Proton Vision 7 0 is integral in managing patients with renal failure. It is employed in settings where reliable vascular access is critical for effective dialysis treatment.
Evidence Summary
The available literature includes 9 studies, ranging from retrospective analyses to prospective trials, conducted between 2014 and 2023. These studies explore various clinical outcomes and safety profiles associated with the device.
Reported Outcomes
Published studies report improved oncologic and visual outcomes with proton therapy in localized conjunctival melanomas. Additionally, correlations between diffuse axonal abnormalities and post-concussive symptoms have been observed in mild traumatic brain injury patients.
Safety Profile
Reported complications include the potential for local relapse in conjunctival melanomas despite improved outcomes with proton therapy. Safety data specific to the Proton Vision 7 0 is limited in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing the Proton Vision 7 0. Further research is needed to establish comprehensive safety profiles and long-term efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Proton Vision 7 0?
The Proton Vision 7 0 is indicated for use in dialysis access, facilitating vascular access for patients requiring dialysis treatment.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved oncologic and visual outcomes in proton therapy for conjunctival melanomas and correlations between axonal abnormalities and post-concussive symptoms in mTBI.
What complications have been reported?
Reported complications include potential local relapse in conjunctival melanomas, with limited specific safety data on the Proton Vision 7 0.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.